FOUNDATION KNEE SYSTEM
FDA 510(k) clearance K923277 · decided 1993-02-09
Clearance details
- K-number
- K923277
- Device name
- FOUNDATION KNEE SYSTEM
- Applicant
- Encore Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-06
- Decision date
- 1993-02-09
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Red Rock, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distr recall (Z-2466-2008) | Encore Medical, Lp | 2008-09-29 |
| Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement. recall (Z-0331-06) | Encore Medical, Lp | 2005-12-29 |
| Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Manufactured by Encore Or recall (Z-1010-04) | Encore Medical, LP | 2004-07-20 |
| Foundation Knee System, non-porous Femur Size 8, Right recall (Z-1069-03) | Encore Medical, LP | 2003-07-30 |